What the label lists and what reports show
Drospirenone and estetrol side effects
Drospirenone and estetrol's FDA label: “Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased” FAERS holds 274 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is intermenstrual bleeding (24 reports).
- No generic listed
- Boxed warning
Check it at the source: the drospirenone and estetrol FDA label on DailyMed (effective May 11, 2023); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NEXTSTELLIS?NEXTSTELLIS may cause serious side effects including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, have high blood pressure, have diabetes, have high cholesterol, or are older than 35 years of age. […]
Source: FDA drug label, Mayne Pharma, effective May 11, 2023 (SPL set c5270073-d083-4109-ae4b-156986175e0a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased
Table 4 Adverse Reactions Occurring in ≥ 2% of Females Receiving NEXTSTELLIS in Studies C301 and C302
| Preferred Term (PT) | Participants with Adverse Reaction – US/Canada Phase 3 trial (n [%]) (N = 2073)… | Participants with Adverse Reaction – Two Phase 3 trials (n [%]) (N=3632) Represents the… |
|---|---|---|
| Any adverse reaction Any adverse reaction equals any adverse event ≥ 2%. | 1205 (58.1) | 2126 (58.5) |
| Mood disturbance Includes PTs: adjustment disorder, affective disorder, agitation, anger,… | 226 (10.9) | 329 (9.1) |
| Bleeding irregularities Includes PTs: abnormal withdrawal bleeding, amenorrhea, cervix… | 201 (9.7) | 393 (10.8) |
| Breast symptoms Includes PTs: anisomastia, breast cyst, breast discoloration, breast… | 110 (5.3) | 197 (5.4) |
| Headache Includes PTs: headache, premenstrual headache, and tension headache. | 100 (4.8) | 227 (6.3) |
| Dysmenorrhea Includes PTs: adnexa uteri pain, dysmenorrhea, premenstrual cramps, pelvic… | 84 (4.1) | 133 (3.7) |
| Weight increased Includes PTs: weight increased, weight fluctuation, body mass index… | 68 (3.3) | 108 (3.0) |
| Acne Includes PTs: acne and cystic acne. | 66 (3.2) | 136 (3.7) |
| Libido decreased/lost Includes PTs: libido decreased and loss of libido. | 27 (1.3) | 72 (2.0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events including venous and arterial thromboembolism [see Boxed Warning and Warnings and Precautions (5.1) ] Hyperkalemia [see Warnings and Precautions (5.2) ] Liver disease [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data provided reflect the experience with the use of NEXTSTELLIS in two large prospective studies, one in Europe/Russia (C301) and one in North America (C302) (N = 3,632) of NEXTSTELLIS for the prevention of pregnancy in females 16-50 years of age. The mean duration of NEXTSTELLIS exposure was 317 and 257 days for the respective studies. The study population was 27 years of age on average, with a mean BMI of 25 kg/m 2 . …
Source: FDA drug label, Mayne Pharma, effective May 11, 2023 (SPL set c5270073-d083-4109-ae4b-156986175e0a), via openFDA; the full label on DailyMed
What do FAERS reports show?
274 reports list drospirenone and estetrol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 21 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Drospirenone and estetrol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions